Belimumab for Interstitial Lung Disease

(BEconneCTD-ILD Trial)

Recruiting at 137 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must be taking: Standard therapy

Disqualifiers: Systemic sclerosis, Rapidly progressive disease, Emphysema, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether belimumab (also known as Benlysta, a type of immunotherapy) can help individuals with interstitial lung disease (ILD) linked to connective tissue diseases (CTDs). ILD can cause lung stiffness and inflammation, leading to symptoms like shortness of breath and fatigue, which can severely impact daily life. Participants will receive either belimumab or a placebo (a harmless pill with no effect) alongside their usual treatment to determine if it improves lung function and symptoms. Suitable candidates include those with CTD-ILD who have experienced worsening lung disease over the past two years, despite maintaining a steady treatment plan. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that participants must be on stable standard therapy for ILD or underlying CTD. It seems likely that you can continue your current treatment.

Is there any evidence suggesting that belimumab is likely to be safe for humans?

Research has shown that belimumab treats certain conditions, such as connective tissue diseases. In past studies, most participants tolerated belimumab well. Reported side effects matched those in the belimumab information, including nausea and infections.

Belimumab already has FDA approval for other conditions, indicating a proven safety record when used correctly. However, since each condition and individual varies, participants should discuss potential risks with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ILD?

Unlike the standard treatments for interstitial lung disease, which typically include corticosteroids and immunosuppressants, belimumab offers a unique approach by targeting and inhibiting the activity of a protein called BLyS (B-lymphocyte stimulator). This mechanism is particularly exciting because BLyS plays a crucial role in the survival and proliferation of B cells, which are involved in the immune response contributing to the disease. By curbing this protein's activity, belimumab has the potential to more precisely modulate the immune system, potentially leading to improved outcomes with fewer side effects. Researchers are hopeful that this targeted action will provide a more efficient and safer option for patients.

What evidence suggests that belimumab might be an effective treatment for interstitial lung disease?

In this trial, participants will receive either belimumab or a placebo alongside standard therapy. A previous case report showed that a patient with lung disease linked to connective tissue problems experienced lasting improvement when belimumab was added to the treatment plan. Early findings suggest that belimumab, combined with standard therapy, may stabilize or improve lung function in this condition. Researchers have studied this treatment for its potential to reduce symptoms like shortness of breath and tiredness. While more research is needed, these early signs are promising for helping people with this lung disease. ^{1 4 5 6 7}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for adults with a lung condition called Interstitial Lung Disease (ILD) that's linked to Connective Tissue Disease (CTD). Participants should have symptoms like reduced lung volume, breathlessness, coughing, and fatigue. The study seeks individuals who can take additional standard therapy alongside the trial treatment.

Inclusion Criteria

I can take my medication by myself or have someone who can help me.

I am on a stable treatment for my lung disease or connective tissue disease, or I couldn't tolerate the first treatment.

I can sign and understand the consent form.

Exclusion Criteria

I have a lung condition that makes it hard to breathe.

My lung scans show more damage from emphysema than from ILD.

I have never had bleeding in my lungs or similar lung problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive belimumab or placebo in addition to standard therapy to assess stabilization and/or improvement of lung function

52 weeks

Regular visits throughout the treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Belimumab

Trial Overview The study is testing Belimumab versus a placebo to see if it helps stabilize or improve lung function and symptoms in patients with ILD associated with CTD. It aims to determine if adding Belimumab to regular treatments offers better outcomes.

How Is the Trial Designed?

Group I: Belimumab Experimental Treatment 1 Intervention

Participants will receive belimumab in addition to standard therapy.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo in addition to standard therapy.

Belimumab is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Benlysta for:

• Systemic lupus erythematosus (SLE)

Approved in European Union as Benlysta for:

• Systemic lupus erythematosus (SLE)

Approved in Canada as Benlysta for:

• Systemic lupus erythematosus (SLE)

Approved in Japan as Benlysta for:

• Systemic lupus erythematosus (SLE)

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Published Research Related to This Trial

In a study of 194 interstitial lung disease (ILD) patients over 12 months, about 30% experienced a significant decline in health-related quality of life (HRQL), as measured by the K-BILD questionnaire and EQ-5D Visual Analog Scale.

Lower baseline lung function, specifically forced vital capacity (FVC) and diffusing capacity of carbon monoxide (DLCO), was linked to HRQL deterioration, highlighting the importance of maintaining lung function to support patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of health-related quality of life decline in interstitial lung disease. Maqhuzu, PN., Szentes, BL., Kreuter, M., et al.[2020]

In a study of 50 patients with severe, progressive interstitial lung disease (ILD) treated with rituximab, there was a significant median improvement in forced vital capacity (FVC) of 6.7% after treatment, indicating potential efficacy as a rescue therapy.

Despite the benefits, there were safety concerns, as two patients experienced serious infections and ten patients died from disease progression within a median of 5.1 months post-treatment, highlighting the need for further research on safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rituximab in severe, treatment-refractory interstitial lung disease. Keir, GJ., Maher, TM., Ming, D., et al.[2022]

In the INBUILD trial involving 170 patients with fibrosing autoimmune disease-related interstitial lung diseases, nintedanib significantly slowed the decline in lung function (measured by forced vital capacity) compared to placebo, with a difference of 102.7 ml/year over 52 weeks.

While nintedanib was effective, it was associated with a higher incidence of adverse events, particularly diarrhea, affecting 63.4% of patients, though most side effects were manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nintedanib in Patients With Autoimmune Disease-Related Progressive Fibrosing Interstitial Lung Diseases: Subgroup Analysis of the INBUILD Trial. Matteson, EL., Kelly, C., Distler, JHW., et al.[2022]

In a study of 216 patients with non-small cell lung cancer (NSCLC), those with interstitial lung disease (ILD) experienced significantly higher rates of nivolumab-related pneumonitis (31% vs. 12%) compared to those without ILD, indicating a greater risk of lung toxicity in this group.

Despite the increased incidence of pneumonitis, most cases were manageable, and no deaths occurred due to nivolumab-related pneumonitis, suggesting that nivolumab can still be a viable treatment option for NSCLC patients with ILD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of nivolumab in non-small cell lung cancer with preexisting interstitial lung disease. Kanai, O., Kim, YH., Demura, Y., et al.[2022]

In the INBUILD trial involving 663 patients with chronic fibrosing interstitial lung diseases, nintedanib significantly reduced the rate of lung function decline (measured by forced vital capacity) compared to placebo, regardless of glucocorticoid use.

The safety profile of nintedanib remained consistent whether patients were using immunomodulatory therapies or not, suggesting it can be safely combined with these treatments in managing progressive fibrosing ILDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nintedanib and immunomodulatory therapies in progressive fibrosing interstitial lung diseases. Cottin, V., Richeldi, L., Rosas, I., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8639321/

Belimumab in the Treatment of Connective Tissue Disease ... To our knowledge, there has been no prior study to quantify the effects of Belimumab or other biologics on CTD-ILD.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06572384

NCT06572384 | A Study of the Efficacy and Safety ... The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or ...

3. ajmc.com ajmc.com/view/case-report-shows-positive-outcome-with-belimumab-for-ctd-associated-interstitial-lung-disease

Case Report Shows Positive Outcome With Belimumab for ... The patient experienced lasting improvement when belimumab was added to her regimen after 2 years.

4. trials.arthritis.org trials.arthritis.org/trials/NCT05878717

A Study of the Efficacy and Safety of Belimumab in Adults With ... The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06572384

Belimumab in Adults With Interstitial Lung Disease ... The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization and/or ...

6. ema.europa.eu ema.europa.eu/en/documents/variation-report/benlysta-h-c-002015-p46-0000253553-epar-assessment-report_en.pdf

Benlysta, INN-belimumab - EMA With regards to safety, the adverse events are in line with those reflected in section 4.8 of the SmPC. Some additional information regarding ...

7. ard.bmj.com ard.bmj.com/content/82/Suppl_1/1668

AB0904 BELIMUMAB FOR THE TREATMENT OF ... We present the design of a global Phase 2/3 study that will test the efficacy and safety of SC belimumab in patients with SSc-ILD.